Back to Agendas
Hear From the Regulators – Current Experiences
Session Chair(s)
Doris Irene Stenver, MD, MPA
Independent Pharmacovigilance Adviser
Unique Advice, Denmark
Three years after the creation of the Pharmacovigilance Risk Assessment Committee (PRAC) a lot of experience has been gained with the new procedures put in place to strengthen public health. In order to fulfill their obligations QPPVs must keep abreast with developments in the PRAC. This session will take stock of PRAC achievements to date and will also focus on the important link between this committee and the CHMP/CMD(h). Furthermore the session will provide regulatory insight regarding the handling of the periodic safety update reports, a tool which has become of increasing importance, forming the basis for frequent benefit/risk assessments of medicinal products. The session will also include an update on the continued work with optimizing risk minimization measures and methods suitable for measuring their effectiveness.
Speaker(s)
PRAC Activities Overview and Collaboration Between PRAC and CHMP (Scientific Committee) / CMDh (Regulatory Committee)
June Raine, MD, MSc, FRCP
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Executive
PSUR Concept as a Benefit:Risk Tool – Practical Aspects
Jolanta Gulbinovic
State Medicines Control Agency , Lithuania
Chief Expert in Drug Safety; PRAC Member
Have an account?